Adapting to Adaptive Licensing
EMA’s pilot project continues. Is the future of regulation adaptive?
Stephanie Sutton |
Lynn Baird referred to adaptive licensing as the “future of licensing” in the November issue of The Medicine Maker (“Adapting to the Future of Licensing” [tmm.txp.to/0214/adapting]) and it seems that many companies feel the same way. A recent progress report released by the European Medicines Agency (EMA) shows that 34 submissions had been received as of December 2014 for its adaptive licensing pilot project – Adaptive Pathways.
Adaptive licensing has a more staggered approval process, with the medicine first authorized in a restricted patient population under close monitoring. If all goes well, the marketing authorization can gradually be expanded to new patient populations, with data being accumulated along the way.
The majority of the requests received by the EMA related to anticancer medicines and orphan medicines, and six submissions have now been selected for what the EMA refers to as a ‘Stage II meeting’, which involves an in-depth discussion with all stakeholders. One such meeting has already taken place and the others are planned for 2015.
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